B-cell Immunity to Influenza (SLVP017)- Year 5, 2013

NCT ID: NCT03020537

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2013-12-31

Brief Summary

In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different vaccines given to identical twins and vaccine-naive young adults.

Detailed Description

This is a study of healthy children and adults who will be given standard seasonal influenza vaccination (IIV3). There are no exclusions for gender, ethnicity or race. Following review and confirmation of written informed consent, volunteers will be enrolled into the study.

The 1-2 year-old child volunteers enrolled in Group A cannot have been previously immunized with an influenza vaccine. They will receive two single doses of the 2013-2014 pediatric formulation of seasonal trivalent inactivated influenza vaccine (IIV3), at least 28 days apart, given by intramuscular (IM) injection. The child volunteers will complete 4 clinic visits with 3 blood sample collections. Study visits will be on Day 0 (first immunization), Day 28-32 (second immunization), Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. The baseline blood sample will be drawn prior to immunization at Day 0, followed by two additional blood samples at Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. There will not be a blood sample collected at Day 28-32.

The 18-30 year-old young adults in Group B cannot have been immunized with the 2012-2013 seasonal influenza vaccine. Participants in Group B will receive a single dose of the 2013-2014 IIV3 by IM injection. Young adult volunteers will complete 3 clinic visits with 3 blood sample collections on Day 0, Day 6-8, and Day 28+4. The baseline blood sample will be drawn prior to immunization at Day 0.

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group A: 1-2 years old

Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).

Group Type: OTHER

Fluzone

Intervention Type: BIOLOGICAL

Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.

Group B: 18-30 years old

Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.

Group Type: OTHER

Fluzone

Intervention Type: BIOLOGICAL

Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.

Interventions

Fluzone

Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Healthy, ambulatory children 1-2 years of age or 18-30 year-old young adults.

2. Willing to complete the informed consent process.

3. Availability for follow-up for the planned duration of the study (after last study immunization, approximately 8 weeks for Group A and 4 weeks for Group B).

4. Acceptable medical history by medical history and vital signs.

Exclusion Criteria

1. Group A: Prior vaccination with a seasonal flu vaccine (IIV). Group B: Prior vaccination with the 2012-2013 seasonal flu vaccine (IIV or LAIV).

2. Prior off-study vaccination with the current 2013-2014 seasonal IIV or LAIV

3. Allergy to egg or egg products, or to vaccine components.

4. Life-threatening reactions to previous influenza vaccinations

5. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination

6. History of immunodeficiency (including HIV infection)

7. Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.

8. Chronic Hepatitis B or C.

9. Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible; use of inhaled steroids, or oral steroids (<20mg prednisone-equivalent/day), may be acceptable after review by the investigator.

10. Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).

11. Autoimmune disease (including rheumatoid arthritis) treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.

12. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year

13. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.

14. Receipt of blood or blood products within the past 6 months

15. Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol

16. Inactivated vaccine within 14 days prior to study vaccination (inform study staff of any non-study vaccinations received during study period)

17. Live, attenuated vaccine within 30 days prior to first study vaccination, or planned immunization with a live, attenuated vaccine before completion of study visits (inform study staff of any non-study vaccinations received during study period).

18. Need for allergy immunizations (that cannot be rescheduled if necessary) during the study period

19. History of Guillain-Barre Syndrome

20. Pregnant or lactating woman

21. Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of study visits

22. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment

23. Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Cornelia L. Dekker

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cornelia Dekker, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Harry Greenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Stephen Quake, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Xiaosong He, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

References

Le Gars M, Kay AW, Bayless NL, Aziz N, Dekker CL, Swan GE, Davis MM, Blish CA. Increased Proinflammatory Responses of Monocytes and Plasmacytoid Dendritic Cells to Influenza A Virus Infection During Pregnancy. J Infect Dis. 2016 Dec 1;214(11):1666-1671. doi: 10.1093/infdis/jiw448. Epub 2016 Sep 21.

Reference Type: BACKGROUND

PMID: 27655870 (View on PubMed)

Other Identifiers

2U19AI057229-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SU-17218-2013

Identifier Type: -

Identifier Source: org_study_id